The study is comparing the difference between the use of Elequil Aromatabs versus standard of care practice treatments on Blood Marrow Transplantation patients.
The primary objective is to examine whether there are differences in the level of anxiety and nausea between patients in the treatment and control groups. The secondary objective is to compare the number of as needed (PRN) antiemetics and anxiolytics, as well as the duration of prolonged standardized antiemetic and anxiolytic regimen for the treatment and control cohorts. The sample size of 200 patients is anticipated to be enrolled over a period of 1 year. A total of 50 patients will be enrolled in each of the four groups The enrollment procedure will begin with a screening of patients who are admitted within 24 hours of admission for blood and marrow transplantation conditioning to evaluate if they meet the inclusion criteria. Patients who meet inclusion criteria will be offered an opportunity to participate in the study. The patient will complete an informed consent form, then assessed to identify their predominant symptom:anxiety or nausea. Based on the patients' primary symptom, they will be randomized into either control or treatment group for a total of four groups (nausea treatment, nausea control, anxiety treatment, and anxiety control). The study will be using a Wei's Urn algorithm for the randomization sequence. The randomization sequence and patient information will be stored in a protected SharePoint folder between the 8PE and 8PW nurses enrolled with the Institutional Review Board as study staff. Patients enrolled in the nausea control/treatment group will be required to complete a Generalized Anxiety Disorder 7-Item Scale (GAD-7) form to determine the baseline of anxiety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
There will be a variety of different Aromatabs such as orange/peppermint or lavender
Hackensack University Medical Center
Hackensack, New Jersey, United States
Using the Halpin 0-to-5 Nausea and Vomiting Scales to document the degree of severity of patients' self-reported blood and marrow transplant conditioning regimen induced nausea and vomiting
Differences in the severity of nausea and vomiting between patients in the treatment and control groups
Time frame: 12-hour intervals for a year
Using the Patient Self-Report of Anxiety Assessment Tool to document the degree of severity of patients' self-reported anxiety
Differences in the severity of anxiety between patients in the treatment and control groups
Time frame: 12-hour intervals for a year
Number of PRN antiemetics for prolonged standardized antiemetic regimen
These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts
Time frame: 1 year
Duration of PRN antiemetics for prolonged standardized antiemetic regimen
These are patients who self-report blood and marrow transplant conditioning regimen induced nausea and vomiting in the treatment and control cohorts
Time frame: 1 year
Number of PRN anxiolytics for prolonged standardized anxiolytic regimen
These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts
Time frame: 1 year
Duration of PRN anxiolytics for prolonged standardized anxiolytic regimen
These are patients who self-report blood and marrow transplant conditioning regimen induced anxiety in the treatment and control cohorts
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Time frame: 1 year
Using the Patient Self-Report of Anxiety Assessment Tool to document the severity of anxiety prior to and following application of the patch
The level of anxiety in the hour prior to and following application of the patch for patients in the treatment arm
Time frame: one hour prior to and following application of the patch
Using the Halpin 0-to-5 Nausea and Vomiting Scales to document the severity of nausea/vomiting prior to and following application of the patch
The level of nausea/vomiting in the hour prior to and following application of the patch for patients in the treatment arm
Time frame: one hour prior to and following application of the patch